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Steps (30) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for wholesale medicine  (5) expand_more expand_less
Obtain medicine registration certificate  (4) expand_more expand_less
Obtain medicine export permit  (3) expand_more expand_less
Obtain EAC certificate of origin  (5) expand_more expand_less
Pre-clearance documentation  (2) expand_more expand_less
Custom declaration  (2) expand_more expand_less
Consignment inspection  (2) expand_more expand_less
Obtain release order  (2) expand_more expand_less
Port clearance  (5) expand_more expand_less

certification bar

6
Register and apply for medicine registration certificate
(last modified: 05/10/2021)

You can apply for this step online

language Apply online

Contact details

Entity in charge

RIMS Customer Self Service Portal

Expected results

TMDA profoma invoice.

Requirements

1. Application form for medicine registration
Application form for medicine registration (original)
2. 01 - Libre deuda de patente
Cover letter (original)
Addressed to Director General
3. 01 - Libre deuda de patente
Certificate of incorporation (Simple copy)
For companies incorporated in Tanzania
or 01 - Libre deuda de patente
Certificate of compliance (Simple copy)
For foreign companies (companies are incorporated outside Tanzania mainland and they come in the country as branches of such foreign companies.)
or 01 - Libre deuda de patente
Business registration certificate (Simple copy)
For registered business
4. 01 - Libre deuda de patente
Medicinal product dossier (original)
Contains medicine specification
5. 01 - Libre deuda de patente
Certificate of pharmaceutical product (original)
The certificate should be in WHO format on official papers of the issuing competent authority.
6. 01 - Libre deuda de patente
Medicine samples
7.
Tanzania GMP compliance certitcate (Simple copy)
It is applicable for imported medicine

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   5mn - Max.   10mn

Legal justification

1. The Tanzania Food, Drugs and Cosmetics Act, 2003
The Tanzania Food, Drugs and Cosmetics Act, 2003
Sections 52, 53
2. The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015
The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015
Sections 5, 6

Who certified this information ?

Damas NYANG'ANYI, Ag. Director of Business Support, 18/12/2018

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office

Off Mandela Road, Mabibo - External , Dar es Salaam P.O. Box 77150, Dar Es Salaam
Tel: +255 222 450 512 / +255 222 450 751 / +255 800 110 084
Fax: +255 222 450 793
Email: tmda.go.tz, info@tmda.go.tz
Website: https://www.tmda.go.tz/
Directions: Google maps

Unit in charge

Communication and Public Education Section

Mon: 08:30 - 13:00, 14:00 - 17:00
Tue: 08:30 - 13:00, 14:00 - 17:00
Wed: 08:30 - 13:00, 14:00 - 17:00
Thu: 08:30 - 13:00, 14:00 - 17:00
Fri: 08:30 - 13:00, 14:00 - 17:00
The office is closed during weekend and public holiday.

Person in charge

Gaudensia Simwanza

Manager, Communication and public Education
Tel: +255 713616 263
Email: info@tfda.go.tz, gaudencia.simwanza@tfda.go.tz
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